Evaluation of the effect of multipoint intra-mucosal vaginal injection of a specific cross-linked hyaluronic acid for vulvovaginal atrophy: a prospective bi-centric pilot study.

BACKGROUND: Vulvo-vaginal atrophy (VVA) is one of the common consequences of estrogen deficiency especially after the menopause. Several studies have assessed the effects of Hyaluronic acid (HA) on physical and sexual symptoms associated with VVA with promising results. However, most of these studies have focused on subjective assessment of symptom response to topically administered preparations. Nonetheless, HA is an endogenous molecule and it is logical that its effects are best realized if injected in the superficial epithelial layers. Desirial® is the first crosslinked HA that is administered by injection in the vaginal mucosa. The aim of this study was to explore the effect of multipoint vaginal intra-mucosal injections of specific cross-linked hyaluronic acid (DESIRIAL®, Laboratoires VIVACY) on several clinical and patient reported core outcomes. METHODS: A cohort bi-centric pilot study. The chosen outcomes included change in vaginal mucosa thickness, biological markers for collagen formation, vaginal flora, vaginal pH, vaginal health index, vulvo-vaginal atrophy symptoms and sexual function 8 weeks post Desirial® injection. Patients' satisfaction was also assessed using the patient global impression of improvement (PGI-I) scale. RESULTS: A total of 20 participants were recruited between 19/06/2017 and 05/07/2018. At the end of the study, there was no difference in the median total thickness of the vaginal mucosa or in procollagen I, III or Ki67 fluorescence. However, there was a statistically significant increase in COL1A1 and COL3A1 gene expression (p = 0.0002 and p = 0.0010 respectively). There was also a significant reduction in reported dyspareunia, vaginal dryness, vulvar pruritus, vaginal chafing and significant improvement in all female sexual function index dimensions. Based on PGI-I, 19 patients (95%) reported varying degrees of improvement where, 4 (20%) felt slightly better; 7 (35%) better and 8 (40%) much better. CONCLUSIONS: Multi-point vaginal intra-mucosal injections, of Desirial® (a crosslinked HA) was significantly associated with the expression of CoL1A1 and CoL3A1 suggesting stimulation of collagen formation. Furthermore, there was a significant reduction in VVA symptomatology and a significant improvement in patient satisfaction and sexual function scores. However, there was no demonstrable change in the total vaginal mucosal thickness. Study registration ID-RCB: 2016-A00124-47, Protocol code number: LOCAL/2016/PM-001.

MTHFR (methylenetetrahydrofolate reductase: EC 1.5.1.20) SNPs (single-nucleotide polymorphisms) and homocysteine in patients referred for investigation of fertility.

PURPOSE: MTHFR, one of the major enzymes in the folate cycle, is known to acquire single-nucleotide polymorphisms that significantly reduce its activity, resulting in an increase in circulating homocysteine. Methylation processes are of crucial importance in gametogenesis, involved in the regulation of imprinting and epigenetic tags on DNA and histones. We have retrospectively assessed the prevalence of MTHFR SNPs in a population consulting for infertility according to gender and studied the impact of the mutations on circulating homocysteine levels. METHODS: More than 2900 patients having suffered at least two miscarriages (2 to 9) or two failed IVF/ICSI (2 to 10) attempts were included for analysis of MTHFR SNPs C677T and A1298C. Serum homocysteine levels were measured simultaneously. RESULTS: We observed no difference in the prevalence of different genetic backgrounds between men and women; only 15% of the patients were found to be wild type. More than 40% of the patients are either homozygous for one SNP or compound heterozygous carriers. As expected, the C677T SNP shows the greatest adverse effect on homocysteine accumulation. The impact of MTHFR SNPs on circulating homocysteine is different in men than in women. CONCLUSIONS: Determination of MTHFR SNPs in both men and women must be seriously advocated in the presence of long-standing infertility; male gametes, from MTHFR SNPs carriers, are not exempted from exerting a hazardous impact on fertility. Patients should be informed of the pleiotropic medical implications of these SNPs for their own health, as well as for the health of future children.

Balloon catheter vs oxytocin alone for induction of labor in women with a previous cesarean section: A randomized controlled trial.

INTRODUCTION: The aim of this study was to compare the efficacy and maternal-neonatal morbidity between balloon catheter and oxytocin for induction of labor in women with a previous cesarean section and an unfavorable cervix. MATERIAL AND METHODS: This open-label randomized controlled trial took place in seven French hospitals. Inclusion criteria were medical indication for labor induction in pregnant women, ≥37 weeks, with lower segment cesarean section, Bishop score ≤4, no pre-labor rupture of membranes, singleton fetus in cephalic presentation. Women were allocated randomly to induction with a 50-mL balloon catheter for 12 hours or a low-dose oxytocin infusion. Primary outcome was the rate of vaginal birth. Secondary outcomes were maternal and neonatal complications. RESULTS: The study enrolled 204 women from 26 December 2010 to 31 December 2013: 101 were allocated to receive balloon catheter and 103 to oxytocin. Vaginal birth rate was 50% (n = 51) in the balloon catheter group vs 37% (n = 38) in the oxytocin group (P = 0.050). Maternal and neonatal morbidity did not differ between balloon catheter and oxytocin groups: two uterine dehiscences vs one, one vs four maternal infections, five vs two hemorrhages and 11 vs five neonatal transfers, respectively. Heterogeneity of treatment effect for vaginal delivery was observed across initial Bishop scores. Balloon catheter was more effective for low values of bishop score. CONCLUSIONS: Balloon catheter tended to be associated with a higher probability of vaginal delivery as compared with low-dose intravenous oxytocin when used for induction of labor in women with a previous cesarean section and low Bishop score at induction.

Comparative incidence of pregnancy outcomes in thrombophilia-positive women from the NOH-APS observational study.

The incidence of pregnancy outcomes in women with constitutive thrombophilia is uncertain. We observed women with no history of thrombotic events (nonthrombotic), who had experienced 3 consecutive spontaneous abortions before the 10th week of gestation or 1 fetal death at or beyond the 10th week of gestation. We compared the frequencies of complications during a new pregnancy attempt among women carrying the F5 rs6025 or F2 rs1799963 polymorphism (n = 279; low-molecular-weight heparin [LMWH] treatment during pregnancy only in case of prior fetal death), and women with negative thrombophilia screening results as control women (n = 796; no treatment). Among women with prior recurrent abortions, thrombophilic women were at increased risk for fetal death. Among women with prior fetal death, thrombophilic women experienced less fetal death recurrences, less preterm births and preeclampsia, and more live births as they were treated with LMWH. In nonthrombotic F5 rs6025 or F2 rs1799963 heterozygous women with prior pregnancy loss, fetal loss may indicate a clinical subgroup in which future therapeutic randomized controlled trials testing the effect of LMWH prophylaxis are required in priority.

Comparative incidence of pregnancy outcomes in treated obstetric antiphospholipid syndrome: the NOH-APS observational study.

The incidence of pregnancy outcomes for women with the purely obstetric form of antiphospholipid syndrome (APS) treated with prophylactic low-molecular-weight heparin (LMWH) plus low-dose aspirin (LDA) has not been documented. We observed women without a history of thrombosis who had experienced 3 consecutive spontaneous abortions before the 10th week of gestation or 1 fetal loss at or beyond the 10th week. We compared the frequencies of complications during new pregnancies between treated women with APS (n = 513; LMWH + LDA) and women negative for antiphospholipid antibodies as controls (n = 791; no treatment). Among APS women, prior fetal loss was a risk factor for fetal loss, preeclampsia (PE), premature birth, and the occurrence of any placenta-mediated complication. Being positive for anticardiolipin immunoglobulin M antibodies was a risk factor for any placenta-mediated complication. Among women with a history of recurrent abortion, APS women were at a higher risk than other women of PE, placenta-mediated complications, and neonatal mortality. Among women with prior fetal loss, LMWH + LDA-treated APS women had lower pregnancy loss rates but higher PE rates than other women. Improved therapies, in particular better prophylaxis of late pregnancy complications, are urgently needed for obstetric APS and should be evaluated according to the type of pregnancy loss.

The genital prolapse of Australopithecus Lucy?

INTRODUCTION AND HYPOTHESIS: The female bony pelvis has to fulfil opposing functions: it has to be sufficiently closed to support the pelvic viscera in the upright position, while remaining sufficiently open to allow vaginal delivery. We aim to give an evolutionary perspective and the possible evolution of the bony pelvis from Lucy to the modern female with the implications in terms of genital prolapse. METHODS: Thirteen pelvimetric measurements were performed on 178 bony pelves: 1 fossil pelvis from Australopithecus Lucy, 128 female Caucasian modern adult pelves and 49 female Catarrhine pelves (29 gorillas and 20 chimpanzees). RESULTS: Lucy's pelvis shape was the most transversely oval, short and broad, termed platypelloid. Modern female pelves were transversely oval only at the inlet. A protruding ischial spine, fairly small ischial tuberosities and a sacral concavity made Lucy closer to Homo sapiens and less like the great apes. In the last group, pelvic planes were anteroposteriorly oval, except in the gorilla, where the outlet was round or slightly transversely oval. The subpubic angle was narrowest in Lucy, whereas it was greater than 90° in the great apes. CONCLUSIONS: The female pelvis is involved in both visceral support and parturition and represents a compromise. The narrower pelvis of Australopithecus Lucy provided protection against genital prolapse, but resulted in complex obstetrical mechanics. From an evolutionary perspective, the pelvis of Homo sapiens became modified to make parturition easier, but increased the risk of genital prolapse: the ilia became wide open laterally and the sacrum broadened with a shorter distance between the sacroiliac and coxofemoral joints.

Success factors for Bakri™ balloon usage secondary to uterine atony: a retrospective, multicentre study.

BACKGROUND: Post-partum haemorrhage (PPH) is one of the major obstetric complications and remains a cause of avoidable maternal mortality and morbidity. AIMS: The aims of this study were to assess the success and practicability of a Bakri™ balloon intrauterine tamponade for PPH and evaluate the predictive factors for success. MATERIALS AND METHODS: Women who received the Bakri™ balloon secondary to uterine atony and subsequent failure of routine drug treatment were identified at 6 hospital sites. Demographic, obstetric and specific factors in regard to the Bakri™ balloon use were recorded. Factors predictive of Bakri™ balloon success were evaluated. RESULTS: Intrauterine Bakri™ balloon tamponade was used in 36 women with uterine atony of which 28 received the balloon treatment after vaginal delivery: more than 50% of women (16/28) presented with PPH with blood loss > 1000 mL (mean blood loss: 1130 mL). Two balloon insertions failures were identified. Bakri balloon success was 100% for women with bleeding < 1000 mL. Twenty-five women (69%) did not require invasive treatment; seven (19%) required arterial embolisation and four (11%) surgical management. No short-term complication was observed after balloon insertion. CONCLUSION: The use of the Bakri™ balloon method, if undertaken early, is effective for the management of PPH with uterine atony (100% success compared to 69% overall success rate). Intrauterine balloon tamponade should included in PPH management guidelines.

Comparative incidence of a first thrombotic event in purely obstetric antiphospholipid syndrome with pregnancy loss: the NOH-APS observational study.

The incidence of thrombosis in the purely obstetric form of antiphospholipid syndrome is uncertain. We performed a 10-year observational study of 1592 nonthrombotic women who had experienced 3 consecutive spontaneous abortions before the 10th week of gestation or 1 fetal death at or beyond the 10th week of gestation. We compared the frequencies of thrombotic events among women positive for antiphospholipid Abs (n = 517), women carrying the F5 6025 or F2 rs1799963 polymorphism (n = 279), and women with negative thrombophilia screening results (n = 796). The annual rates of deep vein thrombosis (1.46%; range, 1.15%-1.82%), pulmonary embolism (0.43%; range, 0.26%-0.66%), superficial vein thrombosis (0.44%; range, 0.28%-0.68%), and cerebrovascular events (0.32%; range, 0.18%-0.53%) were significantly higher in aPLAbs women than in the other groups despite low-dose aspirin primary prophylaxis. Women carrying 1 of the 2 polymorphisms did not experience more thrombotic events than women who screened negative for thrombophilia. Lupus anticoagulant was a risk factor for unprovoked proximal and distal deep and superficial vein thrombosis and women in the upper quartile of lupus anticoagulant activity had the highest risk. Despite data suggesting that aPLAbs may induce pregnancy loss through nonthrombotic mechanisms, women with purely obstetric antiphospholipid syndrome are at risk for thrombotic complications.

Genitourinary syndrome of menopause in patients with breast cancer treated by hormonotherapy: women's perception in ITAC, a French web-based survey.

OBJECTIVE: To describe frequency, intensity and impact of genito-urinary syndrome of menopause (GUSM) in breast cancer (BC) survivors receiving hormonotherapy (HT). METHODS: Web-based survey hosted on the Seintinelles website (database of patients and caregivers). Specific questionnaire of 43 questions, including sociodemographic characteristics, history of BC, characteristics of HT, side effects other than GUSM, symptoms of GUSM (frequency, intensity, treatment, and impact) and overall expectations regarding treatment. RESULTS: Among 1157 participants, 96.4% had at least one GUSM symptom. Percentages with at least one urinary, gynecological, or sexual symptom were 56.0%, 85.6% and 86.1% respectively while 70.3% and 10% declared at least 5 and 10 symptoms respectively. Mean (SD) and median (range) numbers of symptoms were 5.9 (2.8) and 6 (0-14) respectively. Most frequently reported symptoms were decreased desire (77.8%), decreased arousal (71.4%), and vaginal dryness 68.4%). On a scale from 0 (no impact) to 10 (maximal impact), the most important impact was reported for sexual life (mean: 6.6±3.5) followed by psychological condition/self-image (mean 5.4±3.1), and relations with partners (mean: 5.1±3.4). Only 13.6% of participants had received information on GUSM prior to the survey. CONCLUSIONS: GUSM remains underdiagnosed and underestimated in BC survivors who receive HT, although it is among most frequent and disabling side effects of HT. Awareness should be increased among physicians, along with information to women. Early detection and treatment of symptoms and prophylaxis of GUSM in at-risk women should be implemented.

[Objective assessment of symptoms and informing patients of surgical risks]. / Evaluation objective des symptomes et information des patientes.

Genital prolapse is a functional pathology presenting with numerous urinary, genito-sexual, and anorectal symptoms. These symptoms are responsible for an alteration of the quality of life, sometimes associated to a real anxiety-depressive syndrome. Because of these complex intricacies, the management of these disorders became multidisciplinary. Tools to measure the impact of prolapse symptoms on the quality of life became a necessity. Such instruments should allow a correlation of the functional symptomatology at the anatomic stage, raise a surgical indication based on the functional disturbance and evaluate the effectiveness and tolerance of the various therapeutic procedures. Two validated self-questionnaires in French (short versions of the Pelvic Floor Distress Inventory [PFDI-20] and the Pelvic Floor Impact Questionnaire [PFIQ-7]) are presently available. Moreover, the physician has the legal obligation to provide detailed presurgical information on frequent and severe hazards, expected benefits, functional consequences, therapeutic alternatives and the consequences of nonintervention. Before surgery takes place, the surgical approach, the benefit of using synthetic prostheses, the possibility of uterine and/or ovarian conservation, and some risky conditions such as smoking, obesity and estrogen deficiency should be discussed.

[Photobiomodulation and vulvovaginal disorders after anticancer treatments]. / Photobiomodulation et troubles vulvovaginaux après traitements anticancéreux.

Anticancer treatments induce vulvovaginal complications that alter the quality of life and sexuality of patients. New technologies, such as photobiomodulation, could address this problem, for which few effective therapeutic solutions exist. The objective of this study was to describe the characteristics of patients seeking treatment and to observe the effects of photobiomodulation. This is a prospective cohort of patients treated for cancer, in failure of first-line medical treatment, managed at the University Hospital of Nîmes. The history, symptoms and impact of the disorders on their quality of life were collected. At follow-up, improvement was assessed using the PGI-I and FSFI questionnaires. Twenty-eight patients were treated. They were all menopausal, half of them after anticancer treatments [chemotherapy (78%), radiotherapy (36%), hormone therapy (36%)]. The main symptom reported was vaginal dryness (72%). Seventy-one percent of patients (n=20) felt that their daily life was affected≥8/10. All patients had sexual dysfunction. Twenty-two patients received at least 6 sessions of photobiomodulation. Seventy-two percent (n=18) of patients felt better or much better after treatment (PGI-I≤2). The median improvement estimated by the patients was 65% (Q1=50%; Q3=72.5%). There was also a significant clinical improvement. No serious adverse events were reported. Due to the small number of patients in a heterogeneous population with no control group, we cannot extrapolate our results. However, the objective was to assess the status of these pathologies and the contribution of photobiomodulation in patients who have failed first-line treatment; and these results are encouraging.

Effectiveness and Costs of Molecular Screening and Treatment for Bacterial Vaginosis to Prevent Preterm Birth: The AuTop Randomized Clinical Trial.

Importance: Bacterial vaginosis (BV) is a well-known risk factor for preterm birth. Molecular diagnosis of BV is now available. Its impact in the screening and treatment of BV during pregnancy on preterm births has not been evaluated to date. Objective: To evaluate the clinical and economic effects of point-of-care quantitative real-time polymerase chain reaction screen and treat for BV in low-risk pregnant women on preterm birth. Design, Setting, and Participants: The AuTop trial was a prospective, multicenter, parallel, individually randomized, open-label, superiority trial conducted in 19 French perinatal centers between March 9, 2015, and December 18, 2017. Low-risk pregnant women before 20 weeks' gestation without previous preterm births or late miscarriages were enrolled. Data were analyzed from October 2021 to November 2022. Interventions: Participants were randomized 1:1 to BV screen and treat using self-collected vaginal swabs (n = 3333) or usual care (n = 3338). BV was defined as Atopobium vaginae (Fannyhessea vaginae) load of 108 copies/mL or greater and/or Gardnerella vaginalis load of 109 copies/mL or greater, using point-of-care quantitative real-time polymerase chain reaction assays. The control group received usual care with no screening of BV. Main Outcomes and Measures: Overall rate of preterm birth before 37 weeks' gestation and total costs were calculated in both groups. Secondary outcomes were related to treatment success as well as maternal and neonate health. Post hoc subgroup analyses were conducted. Results: Among 6671 randomized women (mean [SD] age, 30.6 [5.0] years; mean [SD] gestational age, 15.5 [2.8] weeks), the intention-to-treat analysis of the primary clinical and economic outcomes showed no evidence of a reduction in the rate of preterm birth and total costs with the screen and treat strategy compared with usual care. The rate of preterm birth was 3.8% (127 of 3333) in the screen and treat group and 4.6% (153 of 3338) in the control group (risk ratio [RR], 0.83; 95% CI, 0.66-1.05; P = .12). On average, the cost of the intervention was €203.6 (US $218.0) per participant, and the total average cost was €3344.3 (US $3580.5) in the screen and treat group vs €3272.9 (US $3504.1) in the control group, with no significant differences being observed. In the subgroup of nulliparous women (n = 3438), screen and treat was significantly more effective than usual care (RR, 0.62; 95% CI, 0.45-0.84; P for interaction = .003), whereas no statistical difference was found in multiparous (RR, 1.30; 95% CI, 0.90-1.87). Conclusion and Relevance: In this clinical trial of pregnant women at low risk of preterm birth, molecular screening and treatment for BV based on A vaginae (F vaginae) and/or G vaginalis quantification did not significantly reduce preterm birth rates. Post hoc analysis suggests a benefit of screen and treat in low-risk nulliparous women, warranting further evaluation in this group. Trial Registration: ClinicalTrials.gov Identifier: NCT02288832.

Low-dose aspirin to prevent preeclampsia and growth restriction in nulliparous women identified by uterine artery Doppler as at high risk of preeclampsia: A double blinded randomized placebo-controlled trial.

INTRODUCTION: This trial evaluates whether daily low-dose aspirin initiated before 16 weeks of gestation can reduce preeclampsia and fetal growth restriction in nulliparous women identified by first-trimester uterine artery Dopplers as at high risk of preeclampsia. METHODS: This randomized, blinded, placebo-controlled, parallel-group trial took place in 17 French obstetric departments providing antenatal care. Pregnant nulliparous women aged ≥ 18 years with a singleton pregnancy at a gestational age < 16 weeks of gestation with a lowest pulsatility index ≥ 1.7 or a bilateral protodiastolic notching for both uterine arteries on an ultrasound performed between 11+0 and 13+6 weeks by a certified sonographer were randomized at a 1:1 ratio to 160 mg of low-dose aspirin or to placebo to be taken daily from inclusion to their 34th week of gestation. The main outcome was preeclampsia or a birthweight ≤ 5th percentile. Other outcomes included preeclampsia, severe preeclampsia, preterm preeclampsia, preterm delivery before 34 weeks, mode of delivery, type of anesthesia, birthweight ≤ 5th percentile and perinatal death. RESULTS: The trial was interrupted due to recruiting difficulties. Between June 2012 and June 2016, 1104 women were randomized, two withdrew consent, and two had terminations of pregnancies. Preeclampsia or a birthweight ≤ 5th percentile occurred in 88 (16.0%) women in the low-dose aspirin group and in 79 (14.4%) in the placebo group (proportion difference 1.6 [-2.6; 5.9] p = 0.45). The two groups did not differ significantly for the secondary outcomes. CONCLUSION: Low-dose aspirin was not associated with a lower rate of either preeclampsia or birthweight ≤ 5th percentile in women identified by their first-trimester uterine artery Doppler as at high risk of preeclampsia. TRIAL REGISTRATION: (NCT0172946).

Virulence potential of Escherichia coli strains causing asymptomatic bacteriuria during pregnancy.

We compared the virulence properties of a collection of asymptomatic bacteriuria (ABU) Escherichia coli strains to urinary tract infection (UTI) strains isolated from pregnant women in a university hospital over 1 year. The in vitro and in vivo studies suggest that ABU strains presented a virulence behavior similar to that of strains isolated from cases of cystitis.

Correlation between shrinkage and infection of implanted synthetic meshes using an animal model of mesh infection.

INTRODUCTION AND HYPOTHESIS: the aim of this study was to evaluate a link between mesh infection and shrinkage. METHODS: twenty-eight Wistar rats were implanted with synthetic meshes that were either non-absorbable (polypropylene (PP), n = 14) or absorbable (poly (D: ,L: -lactic acid) (PLA94), n = 14). A validated animal incisionnal abdominal hernia model of mesh infection was used. Fourteen meshes (n = 7 PLA94 and n = 7 PP meshes) were infected intraoperatively with 10e6 CFU Escherichia coli, and compared with 14 non-infected meshes (n = 7 PLA94 and n = 7 PP meshes) (control groups). Explantations were performed on day 30. Shrinkage was evaluated by a reproducible numerical analysis of mesh area. Infection and histological study were evaluated on day 30. RESULTS: non-infected meshes were less shrunk than infected meshes for both non-absorbable (5.0 ± 1.7% versus 21.6 ± 6.1%, p < 0.05) and absorbable meshes (2.4 ± 0.9% versus 11.0 ± 2.5%, p < 0.05). CONCLUSION: this study highlights a link between infection and shrinkage in the model used.

In vitro and in vivo assessment of silver-coated polypropylene mesh to prevent infection in a rat model.

INTRODUCTION AND HYPOTHESIS: The purpose of this study is to determine the effect of silver coating of polypropylene implants on infection in hernia surgery. METHODS: Silver-coated and non-silver-coated large pore monofilament polypropylene mesh implants were compared with and without infection (four groups). The implants were inserted in the abdominal wall of female Wistar rats. An Escherichia coli strain was inoculated intraoperatively in the two infected groups. The implants were removed, and clinical, bacteriological, and histological analyses were performed at 2, 15, and 30 days postoperatively. RESULTS: Eighty-four rats were studied. All inoculated rats (n = 21) in the non-silver-coated polypropylene group presented periprosthetic E. coli infection, compared with only five inoculated rats in the silver-coated polypropylene group (p < 0.0001). Erosion was significantly higher in the infected than in the non-infected silver-coated polypropylene groups (p < 0.01). There was no histological difference between the four groups. CONCLUSIONS: Silver-coated implants appear effective against bacterial infection in our rat model, with good histological tolerance but delayed healing.

A prospective cohort study of postpartum glucose metabolic disorders in early versus standard diagnosed gestational diabetes mellitus.

Early gestational diabetes mellitus (eGDM) is diagnosed when fasting plasma glucose before 24 weeks of gestation (WG) is ≥ 5.1 mmol/L, whilst standard GDM is diagnosed between 24 and 28 WG by oral glucose tolerance test (OGTT). eGDM seems to have worse obstetric outcomes than standard GDM. We compared the rates of postpartum glucose metabolism disorders between women with early versus standard GDM in this prospective study on women with GDM from three university hospitals between 2014 and 2016. Patients were included if they were < 24 WG with at least one risk factor for GDM and excluded if they had type 2 diabetes. Patients were assigned to Group 1 (G1) for eGDM according to IADPSG: fasting blood glucose < 24 WG between 5.1 and 7 mmol/L. Group 2 (G2) consisted of patients presenting a standard GDM at 24-28 WG on OGTT results according to IADPSG: T0 ≥ 5.1 mmol/L or T60 ≥ 10.0 mmol g/L or T120 ≥ 8.5 mmol/L. The primary outcome was postpartum OGTT result. Five hundred patients were analysed, with 273 patients undergoing OGTT at 4-18 weeks postpartum: 192 patients in G1 (early) and 81 in G2 (standard). Patients in G1 experienced more insulin therapy during pregnancy than G2 (52.2% versus 32.5%, p < 0.001), but no patients were taking insulin postpartum in either group. G1 patients experienced less preterm labour (2.6% versus 9.1%, p = 0.043), more induced deliveries (38% versus 25%, p = 0.049) and reduced foetal complications (29.2% versus 42.0%, p = 0.048). There was no significant difference in the rate of postpartum glucose metabolism disorders (type 2 diabetes, impaired glucose tolerance, impaired fasting glycaemia) between groups: 48/192 (25%) in G1 and 17/81 (21%) in G2, p = 0.58. Thus the frequency of early postpartum glucose metabolism disorders is high, without difference between eGDM and standard GDM. This supports measurement of fasting plasma glucose before 24 WG and the threshold of 5.1 mmol/L seems appropriate until verification in future studies.Trial registration: NCT01839448, ClinicalTrials.gov on 22/04/2013.

The first pelvic examination: A rite of passage for the women. A qualitative study about French women.

Background: French general practitioners (GP) and gynaecologists can make use of recommendations when performing a patient's first pelvic examination. The indications and techniques for this examination are clear. The relational aspects and experience of the patients have been dealt with little.Objectives: To analyse and understand the experience of French women during their first pelvic examination to propose practice recommendations based on their experiences.Methods: Qualitative semi-structured interviews was conducted with 13 French women aged 18-30 years recruited from the surgery of a general practitioner using the snowball method. The data were analysed using an inductive method.Results: The first pelvic examination was considered an indispensable rite of passage into adulthood and the life of a woman. They wanted a preparation for a consultation devoted to the first pelvic examination, with a time that is adapted to each woman. A patient-centred practitioner was more important than the pelvic examination itself.Conclusion: Women requested for a general practitioner or a gynaecologist with a deeper understanding of a woman's experience to perform their first pelvic examination. We propose practical recommendations: the following 3 phases for the consultation: before the pelvic examination where the women and the practitioners may get to know one another; during the examination, which would involve the technical aspects and the associated procedures; and after the examination, where the patients and the practitioners review the experience and discuss prevention.

The A6936G polymorphism of the endothelial protein C receptor gene is associated with the risk of unexplained foetal loss in Mediterranean European couples.

The endothelial protein C receptor (EPCR) is expressed by trophoblast cells. Mid-gestation pregnancy loss is described in animals with a haemochorial placenta lacking EPCR. The A6936G allele of the EPCR gene (PROCR) may be associated with lower EPCR densities on trophoblasts, but data are lacking for its effect on the risk of pregnancy loss in humans. A 1:2 case-control study on unexplained pregnancy loss was nested in the NOHA First cohort: 3,218 case couples and 6,436 control couples were studied for PROCR A6936G, coagulation factor V gene (F5) G1691A and coagulation factor II gene (F2) G20210A polymorphisms. Ethnicity and time of pregnancy loss defined through biometry-based gestational ages (embryonic loss < 10(th) week > or = foetal loss) were analysed. The PROCR A6936G allele, in mothers and fathers, was associated only with foetal loss in both Europeans and non-Europeans. Increasing probability levels of carrying a homozygous child were increasingly associated with the risk of foetal demise. The F5 G1691A and F2 G20210A alleles, only in mothers, were only and independently associated with foetal loss in Europeans. In our population, the PROCR A6936G allele describes women, but also men and thus couples, at risk for first unexplained foetal loss. This risk is independent of the foetal loss risk conferred to our local Mediterranean European women by the F5 G1691A and F2 G20210A alleles. Data confirm that the relationship between thrombophilias and pregnancy loss varies according to ethnicity and loss type.

Analysis of the venous thromboembolic risk associated with severe postpartum haemorrhage in the NOHA First cohort.

Severe postpartum haemorrhages (PPH) are responsible for maternal morbidity/mortality. Their complex management sometimes requires haemostatic supplementation, and therapeutic trials on fibrinogen or activated factor VII, which may add to the thrombotic risk, are currently being considered. Furthermore, there is a risk of venous thromboembolism (VTE) during the postpartum period, hence we studied the relationship between severe PPH and VTE in women during their first pregnancy. Among the 32,463 women enrolled between January 1, 1999 and February 1, 2004 in the NOHA First cohort, 317 developed severe PPH, 11 postpartum VTE and 60 had postpartum superficial vein thrombosis (SVT). In the women with severe PPH, whilst there were no episodes of VTE, there were three episodes of SVT, which occurred 6 weeks postpartum. All of the women with severe PPH received packed red blood cell (RBC) units, 29 (9.1%) platelets units, 51 (16.1%) fresh frozen plasma and 29 (9.1%) fibrinogen concentrates. Three patients with both severe PPH and SVT received only packed RBC. Severe PPH or packed RBC unit transfusion were associated with postpartum SVT (adjusted relative risk: 5.3 (1.6-17) and 4.7 (1.5-15) respectively), independent of caesarean section delivery and low-molecular-weight heparin (LMWH) use in the postpartum, but were not independent indicators of one another. This the VTE and SVT risks associated with severe PPH are low (<1% and <2%, respectively). Severe PPH increases the risk of postpartum SVT, but transfusion with platelet units and plasma supplementation using fresh frozen plasma or fibrinogen concentrates do not markedly modulate the risk of venous thrombosis.